The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:

The functional capability of the islet allograft to normalize glucose metabolism in the absence of insulin therapy. [ Time Frame: Outcome measures will be assessed at protocol prescribed intervals. Long term outcomes assessment will be measured at 5 years post transplant or all evidence of islet function has ceased plus six months. ]

Secondary Outcome Measures:

Reduction in insulin requirements in those patients who do not achieve insulin independence with improved metabolic control. [ Time Frame: Outcome measures will be assessed at protocol prescribed intervals. ]

Treatment option 'A'-Two weeks treatment with etanercept. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two weeks.

Other Name: Enbrel

Active Comparator: 2

Two months etanercept treatment post islet transplant

Drug: etanercept

Etanercept will be given for a total of 2 months. The first dose of 50mg in normal saline will be given intravenously one hour before transplant. Then 25mg will be administered subcutaneously two times a week for two months.

Other Name: Enbrel

Eligibility

Ages Eligible for Study:

18 Years to 60 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.

Exclusion Criteria:

Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)

Active infections (clinically or by laboratory testing)

History of current malignancy or suspicion of malignancy until properly investigated and excluded

Liver or biliary abnormalities

Unstable cardiovascular disease

Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784966